Carbon Ion Followed by Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases

Shanghai Proton and Heavy Ion Center

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: proton plus carbon ion radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT05106699

SPHIC-TR-PCa2021-01

Details and patient eligibility

About

The present of clinically pelvic lymph node positive (cN1) represent one of the most important prognostic factors for recurrence and cancer-specific mortality of prostate cancer patients. Approximately 12% of prostate cancer patients present with cN1 disease at the time of diagnosis. Furthermore, with the advent of more sensitive advance diagnostic imaging techniques, such as PSMA PET/CT, the likelihood that pelvic nodes will be found earlier and more frequently.

Unfortunately, The optimal treatment for patients with cN1 still remains unclear. Androgen deprivation therapy (ADT) is the cornerstone of prostate cancer with pelvic lymph node metastasis. Some retrospective and database studies have shown that addition of local radiotherapy (RT) to ADT improve the treatment outcome. The 2022 NCCN guideline recommend RT combined with 2 to 3 years ADT in patients with initially diagnosed cN1 prostate cancer who have a life expectancy greater than 5 years.

Enrollment: 54 estimated patients

Sex: Male

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven initial diagnosis of adenocarcinoma of the prostate;
• Clinical stage T1-4 N0 M0;
• Prostatic assessment by multiparametric (mp) MRI;
• Pelvic lymph node was assessed by PSMA PET/CT and mpMRI;
• No distant metastasis was proven by PSMA PET/CT;
• Patients may received neoadjuvant hormonal therapy;
• 45≤ Age ≤85;
• Adequate performance status (ECOG 0-1);
• No previous pelvic radiation therapy (RT);
• No previous prostatectomy;
• No previous invasive cancer (within 5 years before the prostate cancer diagnosis);
• Ability to understand character and individual consequences of the clinical trial;
• Written informed consent;

Exclusion criteria

• No pathologically confirmed adenocarcinoma of the prostate;
• Distant metastasis (M1);
• Previous pelvic radiotherapy;
• Previous prostatectomy;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Carbon ion followed by Proton radiotherapy

Experimental group

Description:

All patients received whole pelvis and prostate region radiotherapy. The dose to metastatic LN was escalated using simultaneous integrated boost (SIB) technique.

Treatment:

Radiation: proton plus carbon ion radiation